Biomedical subjects
Peter Rosen
Publications and source records attributed to Peter Rosen.
Paramedic-administered neuromuscular blockade improves prehospital intubation success in severely head-injured patients.
BACKGROUND: The purpose of this study was to evaluate the effect of paramedic-administered neuromuscular blocking agents as part of a rapid-sequence intubation (RSI) protocol on successful intubation of severely head-injured patients in a large, urban prehospital system. METHODS: Adult head-injured patients were prospectively enrolled over 1 year using these inclusion criteria: Glasgow Coma Scale (GCS) score of 3 to 8, transport time > 10 minutes, and inability to intubate without RSI. Midazolam and succinylcholine were administered before laryngoscopy; rocuronium was given after tube placement was confirmed using capnometry, syringe aspiration, and pulse oximetry. The Combitube was used as a salvage airway device. All adult trauma victims with a GCS score of 3 to 8 were identified during the first 12 months of the study as the trial cohort and from the preceding 12 months as the control cohort. The trial and control cohorts were compared with regard to demographic data, mechanism of injury, initial vital signs, and GCS scores. The primary outcome measure was intubation success, defined as insertion of either an endotracheal tube or a Combitube, with patients stratified by GCS score. RESULTS: The trial cohort (n = 249) and control cohort (n = 189) were similar with regard to demographic data, mechanism of injury, and initial vital signs and GCS scores. Intubation success rates increased significantly during the trial period for all patients and when stratified into GCS score of 3 and GCS score of 4 to 8. The percentage of patients intubated without neuromuscular blocking agents actually increased during the trial period. Although the number of intubations by helicopter flight crews decreased during the trial, the overall use of aeromedical resources did not change. CONCLUSION: Paramedic-administered neuromuscular blockade as part of an RSI protocol improves intubation success in a large, urban prehospital system.
The effect of paramedic rapid sequence intubation on outcome in patients with severe traumatic brain injury.
OBJECTIVE: To evaluate the effect of paramedic rapid sequence intubation (RSI) on outcome in patients with severe traumatic brain injury. METHODS: Adult major trauma victims were prospectively enrolled over two years using the following inclusion criteria: Glasgow Coma Scale (GCS) 3-8, suspected head injury by mechanism or physical examination, transport time > 10," and inability to intubate without RSI. Midazolam and succinylcholine were administered before laryngoscopy; rocuronium was given after tube placement was confirmed using physical examination, capnometry, syringe aspiration, and pulse oximetry. The Combitube was used as a salvage airway device. For this analysis, trial patients were excluded for absence of a head injury (Head/Neck AIS score < 2), failure to fulfill major trauma outcome study criteria, unsuccessful intubation or Combitube insertion, or death in the field or in the resuscitation suite within 30" of arrival. Each study patient was hand matched to three nonintubated historical controls from our trauma registry using the following parameters: age, sex, mechanism of injury, trauma center, and AIS score for each body system. Controls were excluded for Head/Neck AIS defined by a c-spine injury or death in the field or in the resuscitation suite within 30" of arrival. chi 2, odds ratios, and logistic regression were used to investigate the impact of RSI on the primary outcome measures of mortality and incidence of a "good outcome," defined as discharge to home, rehabilitation, psychiatric facility, jail, or signing out against medical advice. RESULTS: A total of 209 trial patients were hand matched to 627 controls. The groups were similar with regard to all matching parameters, admission vital signs, frequency of specific head injury diagnoses, and incidence of invasive procedures. Mortality was significantly increased in the trial cohort versus controls for all patients (33.0% versus 24.2%, p < 0.05) and in those with Head/Neck AIS scores of 3 or greater (41.1% versus 30.3%, p < 0.05). The incidence of a "good outcome" was lower in the trial cohort versus controls (45.5% versus 57.9%, p < 0.01). Factors that may have contributed to the increase in mortality include transient hypoxia, inadvertent hyperventilation, and longer scene times associated with the RSI procedure. CONCLUSION: Paramedic RSI protocols to facilitate intubation of head-injured patients were associated with an increase in mortality and decrease in good outcomes versus matched historical controls.
Phase II trial of irinotecan in combination with amifostine in patients with advanced colorectal carcinoma.
BACKGROUND: Irinotecan is effective in patients with advanced colorectal carcinoma in both first-line and salvage settings but its use can be limited by serious side effects. Amifostine has been shown to reduce the incidence of cisplatin-induced cumulative renal toxicity in patients with advanced ovarian carcinoma and nonsmall cell lung carcinoma. In the current pilot Phase II trial, the authors examined the potential role of amifostine as a protective agent against irinotecan-induced diarrhea and myelosuppression and evaluated an every-2-weeks regimen as an alternative schedule for the administration of irinotecan in patients with previously treated metastatic colorectal carcinoma. METHODS: All patients received amifostine, 740 mg/m2, followed by irinotecan, 250 mg/m2, every 2 weeks. A 6-week cycle of chemotherapy (every 2 weeks for 3 treatments) was chosen to assess toxicity and response. The main objective of the current study was to evaluate the impact of amifostine on gastrointestinal and hematologic toxicity. RESULTS: A total of 22 patients entered the current study. Six of these 22 patients (27%) had WHO Common Toxicity Criteria Grade 3 or 4 diarrhea, including 2 patients (9%) with Grade 4 diarrhea. Eight of 22 patients (36.3%) developed Grade 3 or 4 neutropenia (Grade 4 in 4 of the 22 patients [18%]). Dose reduction was required in 25% of the treatment cycles. Five of the 22 patients (23%) withdrew from the trial due to amifostine toxicity. Of the 15 patients who were evaluable for response, 4 patients (26.6%) had achieved a partial response and 9 (60%) had stable disease as their best response. CONCLUSIONS: The combination of irinotecan with amifostine in patients with previously treated metastatic colorectal carcinoma did not appear to reduce irinotecan toxicity. Amifostine did not appear to interfere with the cytotoxic effect of irinotecan. The results of the current study did demonstrate efficacy and safety of the every-2-weeks irinotecan schedule that was comparable to other established regimens and these results support its feasibility as a reasonable alternative in this disease setting.
Paramedic-performed rapid sequence intubation of patients with severe head injuries.
STUDY OBJECTIVE: We evaluate the ability of paramedic rapid sequence intubation (RSI) to facilitate intubation of patients with severe head injuries in an urban out-of-hospital system. METHODS: Adult patients with head injuries were prospectively enrolled over a 1-year period by using the following inclusion criteria: Glasgow Coma Scale score of 3 to 8, transport time of greater than 10 minutes, and inability to intubate without RSI. Midazolam and succinylcholine were administered before laryngoscopy, and rocuronium was given after tube placement was confirmed by means of capnometry, syringe aspiration, and pulse oximetry. The Combitube was used as a salvage airway device. Outcome measures included intubation success rates, preintubation and postintubation oxygen saturation values, arrival arterial blood gas values, and total out-of-hospital times for patients intubated en route versus on scene. RESULTS: Of 114 enrolled patients, 96 (84.2%) underwent successful endotracheal intubation, and 17 (14.9%) underwent Combitube intubation, with only 1 (0.9%) airway failure. There were no unrecognized esophageal intubations. On arrival at the trauma center, median oxygen saturation was 99%, mean arrival PO2 was 307 mm Hg, and mean arrival PCO2 was 35.8 mm Hg. Total out-of-hospital times were higher when RSI was performed on scene (26 versus 13 minutes). CONCLUSION: Paramedics can use RSI protocols that include neuromuscular blocking and sedative agents to facilitate intubation of patients with head injuries.
Mitoxantrone/ifosfamide/etoposide salvage regimen with rituximab for in vivo purging in patients with relapsed lymphoma.
Treatment with the anti-CD20 antibody rituximab prior to stem cell collection may lead to tumor-free stem cell collections in patients with B-cell lymphoma undergoing autologous stem cell transplantation. To test the feasibility of obtaining polymerase chain reaction (PCR)-negative stem cell collection, 30 patients with a variety of B-cell lymphomas were enrolled in a protocol employing a common MINE (mitoxantrone/ifosfamide/etoposide) salvage regimen with rituximab (in vivo purging). Rituximab 400 mg/m2 was administered weekly for 3 weeks on days 1, 6, and 8 in relation to the last MINE cycle, which was followed by growth factor-stimulated peripheral stem cell collection. The median number of CD34(+) cells/kg was 2.5 million cells/kg collected over a median of 5 days. Polymerase chain reaction amplification for the t (14;18) or the heavy-chain gene rearrangement was performed prior to treatment and on the leukapheresis sample. Out of 15 patients who had a positive PCR signal prior to treatment, 10 had PCR-negative stem cell collections, whereas 5 had PCR-positive stem cell collections. After high-dose chemotherapy and stem cell transplant, all patients with a PCR-positive signal pretreatment became PCR negative. We conclude that rituximab may increase the yield of tumor-free stem cells. Higher rates of PCR negativity have been reported when more intense and protracted chemoimmunotherapy regimens have been employed. The magnitude of clinical benefit and the significance of the PCR analysis in stem cells after rituximab requires larger studies.